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Partial design and development

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Douglas Olds, Mar 1, 2017.

  1. Douglas Olds

    Douglas Olds New Member

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    We are a contract manufacturer that is currently ISO 9001:2008 registered and getting ready for our ISO 9001:2015 audit later this year. We do not make a product line of our own, so we had a design exclusion for ISO 9001:2008. We do assist our customers in product development quite often. Our customers give a criteria on what they want and our sales team and engineers determine determine the best method to manufacture the part and give suggestions on cost savings or improvements. During this process we are in contact with the customer and give them regular updated drawings for their approval. They sign off on the final design before a prototype is made or the item goes into production. At that point we generally consider them owning the design and the responsibilities that go with it.

    My question is if we meet the criteria for section 8.3.2 Design Planning and section 8.3.3 Design Inputs, can we be excluded from section 8.3.4 Design Controls and 8.3.5 Design Outputs because that portion is our customer's responsibility?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Simply ask yourself, "can I change the design without customer approval"? If the answer is no, you're not design responsible, however much you may participate in the process (which is sometimes called "concurrent engineering", "DFM", "DFA" etc) and you should exclude yourselves from that process/control.
     
  3. Jacky_T

    Jacky_T Member

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    I have a question on Douglas's case: his company needs to determine the best method to manufacture the part, so it is treated as a design of process to manufacture the part for the customer?
     
  4. tony s

    tony s Well-Known Member

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    In ISO 9000:2015 section 3.4.8, design and development is defined as
    "set of processes (3.4.1) that transform requirements (3.6.4) for an object (3.6.1) into more detailed requirements for that object"

    The word "object" can be a product, service or process as per section 3.6.1.

    Under Note 3 of section 3.4.8, it specifies that design and development can be categorized into product design and development, service design and development or process design and development.

    If Douglas' company designs and develops their manufacturing process to ensure production of products designed by their customer, IMHO, this can treated as process design and development like in IATF 16949's manufacturing process design.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Isn't it going to depend on how management see their context etc? Simply relating clauses of the standard because they "seem to fit", isn't really applying the requirements in the manner the standard now demands. The section 4 requirements are foundational is determining what falls within the context, is in consideration of their interested parties and so on... (isn't it?)
     
  6. tony s

    tony s Well-Known Member

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    Yes. Definitely. I just need to quote some statements from ISO 9000 (fundamentals and vocabulary) to support my view.

    What's your take with Jacky_T's' question?
     
    Last edited: Mar 4, 2017
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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Great question, Tony! Truly! First place I'd head is the customer's contract. If it says "Please design me a manufacturing process" and they do and deliver it, then they can claim design responsibility. However, in my experience, that's NOT what contract manufacturing is about...
     
  8. tony s

    tony s Well-Known Member

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    I used my experience on TS 16949 in answering Jacky_T's question - where Section 1.2 of ISO/TS 16949:2009 specifies that:
    "The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
    Permitted exclusions do not include manufacturing process design".
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    IMHO, some of these sector specific requirements take things a little too far...
     
  10. tony s

    tony s Well-Known Member

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    Fortunately, ISO 9001:2015 doesn't require design and development of process. Hence, 8.3 is titled "Design and development of products and services".
     
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